On September 10, the EU Court of Justice released a ruling on a case about the calculation of levels of substances of very high concern (SVHCs) in articles under the Registration, Evaluation and Authorization of Chemicals (REACH) regulation. The ruling says that producers must calculate the levels of SVHCs in their products at the level of the “simple” article, rather than at the aggregate level of the “complex” article that is currently being used.
REACH defines an article as “an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition.” In its original guidance on reporting SVHCs in articles, the European Commission suggested that the 0.1% threshold should be based on the weight of the entire article as imported or as provided to the customer. However, six countries (Austria, Belgium, Denmark, France, Germany and Sweden) disagreed with this guidance. The dissenting countries argued that an SVHC that is above the 0.1% level in any individual article (component) within a product may pose a health or environmental risk and should trigger the reporting and communication obligations for the SVHC. The ruling agrees with the dissenting countries’ opinion that the European Commission’s interpretation, as represented in ECHA’s 2011 Guidance, is wrong.
The court ruling directly affects the disclosures required under REACH Article 33 requirements:
Article 33 of Regulation No 1907/2006, as amended, must be interpreted as meaning that, for the purposes of application of that provision, it is for the supplier of a product one or more constituent articles of which contain(s) a substance of very high concern identified in accordance with Article 59(1) of that regulation in a concentration above 0.1% weight by weight of that article, to inform the recipient and, on request, the consumer, of the presence of that substance by providing them, as a minimum, with the name of the substance in question.
This means that manufacturers must understand and report the presence of candidate list SVHCs (current count is 163) at a much lower level in their products than they generally currently do, which means far more work and effort. So rather than disclosing only if the level of an SVHC is above 0.1% by weight of your entire product, you must disclose its presence for each wire, cable, plastic casing, etc. that contains it above 0.1% by weight.
For more information on the REACH Directive, Teresa Bernheim, Federal Institute for Occupational Safety and Health (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin), will provide an update including the recent decision by the EU Court of Justice ruling on articles definition at IPC Conference on Government Regulation on October 13, 2015 in Essen, Germany. For more information, Visit www.ipc.org/government-regulation-conference to view agenda, learn more about conference or register.